About this trial
The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to nurse administered propofol sedation in diagnostic colonoscopies.
• Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with nurse administered propofol sedation (where a nurse gives the patient bolus doses of propofol as deemed necessary)
Participants will:
* Be randomized to either sedation route. * Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective diagnostic colonoscopy in propofol sedation
Able to understand the study information and provide inform consent
ASA I-II
Able to understand and use the patient-controlled sedation device
Disqualifiers
ASA >=III
Known hypersensitivity or contraindication to propofol or any excipient in the formulation.
Pregnancy or breastfeeding.
Inability to provide valid informed consent
Trial design
Parallel
Treatments tested in this trial
Self administred propofol
DrugPatients will self administer propofol by pushing a button. When pushed a dose of 5 mg propofol will be given intravenously. The button can be pushed a maximum of 8 times per minute.
Nurse assisted propofol sedation
DrugThe endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination
Treatment groups
Trial outcomes
Primary outcomes
Patient satisfaction
Patient satisfaction measured using Patient satisfaction with sedation index (PSSI), a validated Likert-scale questionnaire with 13 questions. Each question with 5 ranks (1-5). Minimum score 13 , maximum score 65. Higher score indicates higher satisfaction with the sedation.
Secondary outcomes
Total propofol dose (mg)
Total given dose during the examination
Recovery time
Time to patient is ready for discharge. Patient will be assesed every 15 minutes until ready for discharge, maximum 4 hours
Procedure duration
Time to completion of the procedure (min)
Adverse events
Any adverse events related to sedation within 30 days
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: